WALLFLEX BILIARY
Received Jun 9, 2026 · Event occurred May 7, 2026
Report 3005099803-2026-02399 · MDR key 25452170
Device
Generic name
Biliary Stent System For Benign Strictures
Manufacturer
Boston Scientific CorporationModel number
M00570370Catalog number
M00570370
Lot number
0038652851
Product problems
- Detachment of Device or Device Component
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A TIGHT STRICTURE WAS ENCOUNTERED. WHEN ATTEMPTING TO DEPLOY THE STENT, THE DEVICE SHEARED ABOVE THE YELLOW TRANSITION ZONE, RESULTING IN LOSS OF FORCE TRANSMISSION AND INABILITY TO RETRACT THE SHEATH. IT WAS SUSPECTED THAT THE DEVICE MAY HAVE SHEARED WHILE PASSING THROUGH THE ENDOSCOPE ELEVATOR. ANOTHER WALLFLEX BILIARY RX FULLY COVERED STENT WAS USED TO COMPLETE THE PROCEDURE THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF INNER SHAFT/SHEATH DETACHMENT OF DEVICE OR DEVICE COMPONENT.